Controlled Study of IC14 for Treatment of ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Amyotrophic Lateral Sclerosis Trial: A Randomized, Double-Blind, Placebo-Controlled Study: IC14, a Monoclonal Antibody Against CD14

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04390386
• Other study ID #: ALS04
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2020
• Source: Implicit Bioscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The ALS IC14 Trial is a multi-center, placebo-controlled clinical trial evaluating the safety and efficacy of IC14 for the treatment of ALS

Description:

The ALS IC14Trial is a multi-center, placebo-controlled clinical trial evaluating the safety and efficacy of IC14 for the treatment of ALS. .

The regimen consists of a placebo-controlled trial, meaning that the active investigational product, IC14, and matching placebo will be tested in the regimen.

Participants will have an equal chance to be randomized to treatment or placebo.

Treatment will be administered intravenously every two weeks for 12 weeks. There will be a 4-week follow up after the final dose.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria.

• Age 18 years or older.

• Capable of providing informed consent and complying with study procedures, in the SI's opinion.

• Time since onset of weakness due to ALS = 36 months at the time of the Master Protocol Screening Visit.

• SVC = 50% of predicted capacity for age, height, and sex at the time of the Master Protocol Screening Visit.

• Participants must either not take riluzole or be on a stable dose of riluzole for = 30 days prior to the Master Protocol Screening Visit. Riluzole-naïve participants are permitted in the study.

• Participants must either not take edaravone or have completed at least one cycle of edaravone prior to the Master Protocol Screening Visit. Edaravone-naïve participants are permitted in the study.

• Participants must have the ability to swallow pills and liquids at the time of the Master Protocol Screening Visit and, in the SI's opinion, have the ability to swallow for the duration of the study.

• Geographically accessible to the site.

Exclusion Criteria:

• Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant, according to SI's judgment (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, or clinically significant laboratory abnormality or EKG changes).

• Lab abnormalities include, but are not limited to: Hemoglobin < 10 g/dL, White Blood Cells < 3.0 x 103/mm3, Neutrophils, Absolute = 1000/mm3, Eosinophilia (absolute eosinophil count of = 500 eosinophils per microliter), low platelet counts (< 150 x 109 per liter), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal (ULN), eGFR < 30 mL/min/1.73m2, thyroid-stimulating hormone (TSH) levels >10 mIU/L or <0.01 mIU/L.

• Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent, in the SI's opinion.

• Active cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years.

• Use of investigational treatments for ALS (off-label use or active participation in a clinical trial) within 5 half-lives (if known) or 30 days (whichever is longer) prior to the Master Protocol Screening Visit.

• Exposure at any time to any gene therapies under investigation for the treatment of ALS (off-label use or investigational).

• If female, breastfeeding, known to be pregnant, planning to become pregnant during the study, or of child-bearing potential and unwilling to use effective contraception for the duration of the trial and for 3 months, or longer as specified in each RSA, after discontinuing study treatment.

• If male of reproductive capacity, unwilling to use effective contraception for the duration of the trial and for 3 months, or longer as specified in each RSA, after discontinuing study treatment.

• Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study, in the SI's opinion.

• If a participant is being re-screened, the disqualifying condition has not been resolved, or the mandatory wash-out duration has not occurred.

• For those participating in the optional CSF collection, contraindication to undergoing a lumbar puncture (LP) in the SI's opinion. Participants undergoing the LP must not be currently taking anticoagulation medications such as warfarin that would be a contraindication to LP; aspirin and non-steroidal anti-inflammatories are allowed.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Biological:
• IC14
Monoclonal antibody against CD14

Other:
• Placebo
Identical-appearing diluent

Locations

Country	Name	City	State
United States	Implicit Bioscience	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Implicit Bioscience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease progression	Change in disease severity over time as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) on a scale from 0 (worst) to 48 (best)	24 weeks
Secondary	Respiratory function	Change in respiratory function over time as measured by Slow Vital Capacity (SVC) from 0% (worst) to 100% (best)	24 weeks
Secondary	Muscle strength	Change in muscle strength over time as measured isometrically using hand-held dynamometry (HHD)	24 weeks
Secondary	Survival	Comparison of rate of occurrence between groups.	24 weeks